Comparison of Blood and Urine Profiles of Remogliflozin in Rat PK Study Using a Single and Simple UPLC Method
Published: 2023-05-13
Page: 53-63
Issue: 2023 - Volume 6 [Issue 1]
G. K. Aiswarya
National College of Pharmacy, KMCT Group of Institutions, Manassery, Kozhikode-673602, Kerala, India.
P. C. Indukala
National College of Pharmacy, KMCT Group of Institutions, Manassery, Kozhikode-673602, Kerala, India.
S. Kathirvel
National College of Pharmacy, KMCT Group of Institutions, Manassery, Kozhikode-673602, Kerala, India.
K. Raja Rajeswari *
Department of Pharmaceutical Analysis, Sri Sivani College of Pharmacy, Srikakulam-532 402, Andhra Pradesh, India.
*Author to whom correspondence should be addressed.
Abstract
This study describes a comparison between blood and urine profiles of Remogliflozin simultaneously in a rat pharmacokinetic study using a simple UPLC method. Quantitative determination of Remogliflozin is performed in rat blood with the recovery values in the range of 85-115%. A reversed phase Ultra-performance liquid chromatography (UPLC) with UV detector is used. The method utilizes an Acquity UPLC CSH Fluoro-Phenyl column (150x1mm, 1.7 µm) and a gradient elution with mobile phase consisting of acetonitrile and 0.1% formic acid (15:85) at a flow rate of 0.8 mL min-1. The method adequately resolves the analyte and internal standard (metformin) within a run time of 5 min. The UV detection carried out at 275 nm. In both blood and urine, the detection limit of Remogliflozin is found to be 2 µg mL-1 and the LOQ as 10 µg mL-1. Two profiles were compared by conducting single oral dose in vivo rat PK study after complete validation of the UPLC method.
Keywords: Antidiabetic, remogliflozin, pharmacokinetics, UPLC, rat blood and Urine
How to Cite
Downloads
References
Nashawi Mouhamed, Sheikh Omar, Battisha Ayman, Ghali Abdullah, Chilton Robert. Neural tone and cardio-renal outcomes in patients with type 2 diabetes mellitus. a review of the literature with a focus on SGLT2 inhibitors. Heart Failure Reviews. 2021;26(3):643–652.
Mudaliar S, Armstrong DA, Mavian AA, O'Connor-Semmes R, Mydlow PK, Ye J, et al. "Remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2, improves serum glucose profiles in type 1 diabetes". Diabetes Care. 2012;35(11): 2198–200. DOI:10.2337/dc12-0508
Dharmalingam M, Aravind SR, Thacker H, Paramesh S, Mohan B, et al. Efficacy and safety of remogliflozin etabonate, a new sodium glucose co-transporter-2 inhibitor, in patients with type 2 diabetes mellitus: A 24-week, randomized, double-blind, active-controlled trial. Drugs. 2020;80(6):587-600.
DOI: 10.1007/s40265-020-01285-0. PMID: 32162274; PMCID: PMC7165159.
Dutta D, Jindal R, Mehta D, Khandelwal D, Sharma M, Efficacy and safety of novel sodium glucose cotransporter-2 inhibitor remogliflozin in the management of type 2 diabetes mellitus: A systematic review and meta-analysis. Diabetes Metab Syndr. 2021;15(6). DOI: 10.1016/j.dsx.2021.102315
Kapur A, O'Connor-Semmes R, Hussey EK, Dobbins RL, Tao W, Hompesch M, Smith GA, Polli JW, James CD Jr, Mikoshiba I, Nunez DJ. First human dose-escalation study with remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2 (SGLT2), in healthy subjects and in subjects with type 2 diabetes mellitus. BMC Pharmacol Toxicol. 2013;14:26. DOI: 10.1186/2050-6511-14-26
Hussey EK, Kapur A, O’Connor-Semmes R, Tao W, Rafferty B, Polli JW, James CD, Jr, and Dobbins RL, Safety, pharmacokinetics and pharmacodynamics of remogliflozin etabonate, a novel SGLT2 inhibitor, and metformin when co-administered in subjects with type2 diabetes mellitus. BMC Pharmacol Toxicol. 2013;14:25.
Kapur A. O’Connor-Semmes R. Hussey E, et al. First human dose-escalation study with remogliflozin etabonate (RE) in healthy subjects and in subjects with type 2 diabetes mellitus (T2DM) [509-P]. Diabetes. 2009;58:A136
Komoroski B. Vachharajani N. Feng Y, et al. Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus. Clin Pharmacol Ther. 2009;85:513-519.
Dobbins R. Kapur A. Kapitza C. et al. Remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2 (SGLT2) reduces serum glucose in type 2 diabetes mellitus (T2DM) patients [573-P]. Diabetes. 2009;58:A154
Vidhi D, Patel P, Method development and validation of UV spectrophotometric estimation of remogliflozin etabonate in bulk and its tablet dosage form. Research Journal of Pharmacy and Technology. 2021;14(4):2042-2044.
Available:10.52711/0974-360X.2021.00362
Dimal A.Shah Stability indicating thin-layer chromatographic method for estimation of antidiabetic drug Remogliflozin etabonate, Future journal of pharmaceutical science. 2021;7:83.
Itigimatha N, Chadchan KS, Yallur BC, Hadagali MD, Simple and Sensitive RP HPLC and UV Spectroscopic Methods for the Determination of Remogliflozin Etabonate in Pure and Pharmaceutical Formulations. Turkish Journal of Pharmaceutical Sciences. 2021;19(2). Available:https://doi.org/10.4274/tjps.galenos.2021.55381
Tammisetty MR, Challa BR, Puttagunta SB. A novel analytical method for the simultaneous estimation of remogliflozin and metformin hydrochloride by UPLC/PDA in bulk and formulation application to the estimation of product traces. Turkish Journal of Pharmaceutical Sciences, 2021;18(3):296–305.
Ali SM, Bharath P, Sharif S K, Ramachandran D, et al. Simple and fast stability indicating UPLC method for the simultaneous quantification of vildagliptin and remogliflozin etabonate in bulk drug and formulations. Current trends in biotechnology and pharmacy. 2021; 15:401–407.
Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation Center for Drug Evaluation and Research. Silver Springs, MD: FDA; 2001.
ICH guideline M10 on bioanalytical method validation and study sample analysis EMA/CHMP/ICH/172948/2019.